Objective:This study aims to evaluate the effectiveness and safety of traditional Chinese medicine(TCM)Yiqi Huoxue Bushen(YHB)in treating mild cognitive impairment(MCI),and to explore innovative therapeutic approaches...Objective:This study aims to evaluate the effectiveness and safety of traditional Chinese medicine(TCM)Yiqi Huoxue Bushen(YHB)in treating mild cognitive impairment(MCI),and to explore innovative therapeutic approaches for MCI.Methods:This study shows a multicenter,double-blind,randomized controlled clinical experiment.A total of 150 patients will be recruited and randomly allocated to the YHB group or the placebo group at a ratio of 2:1.The treatment duration is 6 months.The primary outcome is the change in the score of the Alzheimer’s Disease Assessment Scale-Cognitive Subscale(ADAS-Cog).The secondary outcomes include changes in the Activities of Daily Living Scale(ADL),TCM Syndromes Scale,regional homogeneity(ReHo)measured by Resting-state functional magnetic resonance imaging(rs-fMRI),and the composition of the gut microbiota detected by 16S ribosomal ribonucleic acid sequencing.All scales will be assessed at baseline,months 3 and 6,while rs-fMRI and gut microbiota analysis will be conducted at baseline and 6 months.The research study will record and monitor any adverse events(AEs).Conclusions:The findings of this study will provide robust evidence regarding the efficacy and safety of YHB for Mild Cognitive Impairment(MCI),along with insights into a possible mechanism of MCI.Trial enrollment:On March 20,2022,this clinical study was registered at http://www.chictr.org.cn with the ID:ChiCTR2200057884.展开更多
基金supported by the Science and Technology Innovation Project of China Academy of Chinese Medical Sciences(No.C12021A01302).
文摘Objective:This study aims to evaluate the effectiveness and safety of traditional Chinese medicine(TCM)Yiqi Huoxue Bushen(YHB)in treating mild cognitive impairment(MCI),and to explore innovative therapeutic approaches for MCI.Methods:This study shows a multicenter,double-blind,randomized controlled clinical experiment.A total of 150 patients will be recruited and randomly allocated to the YHB group or the placebo group at a ratio of 2:1.The treatment duration is 6 months.The primary outcome is the change in the score of the Alzheimer’s Disease Assessment Scale-Cognitive Subscale(ADAS-Cog).The secondary outcomes include changes in the Activities of Daily Living Scale(ADL),TCM Syndromes Scale,regional homogeneity(ReHo)measured by Resting-state functional magnetic resonance imaging(rs-fMRI),and the composition of the gut microbiota detected by 16S ribosomal ribonucleic acid sequencing.All scales will be assessed at baseline,months 3 and 6,while rs-fMRI and gut microbiota analysis will be conducted at baseline and 6 months.The research study will record and monitor any adverse events(AEs).Conclusions:The findings of this study will provide robust evidence regarding the efficacy and safety of YHB for Mild Cognitive Impairment(MCI),along with insights into a possible mechanism of MCI.Trial enrollment:On March 20,2022,this clinical study was registered at http://www.chictr.org.cn with the ID:ChiCTR2200057884.
